Brilinta

Brilinta is a blood-thinning medication that came to market in 2011. As is the case with some other new-generation anticoagulants, there is currently no approved antidote to reverse internal bleeding that sometimes occurs with the use of Brilinta. The drug has also come under scrutiny due to accusations that AstraZeneca may have skewed results of a Brilinta clinical trial.

What is Brilinta?

Brilinta is a type of blood thinner known as a platelet aggregation inhibitor. It is indicated to:

Prevent heart attack and stroke in people with heart problems (such as unstable angina or a previous heart attack)

Brilinta is usually taken twice per day, and is used in conjunction with a once-daily low-dose aspirin. For the first 12 months of treatment, most patients will be prescribed 90mg Brilinta tablets. After 12 months, they may be transitioned to 60mg tablets.

Brilinta Black Box Warning

The Brilinta label includes a Black Box Warning that, among other things, notes that the drug can cause episodes of severe and potentially fatal internal bleeding. Patients using Brilinta should contact their doctor immediately, if they experience:

Severe, uncontrollable bleeding

Pink, red, or brown urine

Vomit that is bloody or looks like coffee grounds

Red or black stool

Coughing up blood or blood clots

Brilinta Safety Information

Brilinta should not be taken by patients who have a history of bleeding in the brain, are bleeding now, or are allergic to ticagrelor or any of the ingredients in the medication.

Brilinta may cause shortness of breath. Patients should contact their doctor if they experience any unexpected shortness of breath.

Brilinta may cause dizziness. Patients using this medication should not drive, use machinery, or do any activity that requires alertness until they are sure they can perform such activities safely.

Because Brilinta may cause stomach bleeding, patients should limit their use of alcoholic beverages. Consumption of alcohol may increase the risk of a stomach bleed.

Brilinta patients should check with their doctor if they experience any of the following:

Difficult or labored breathing

Shortness of breath

Tightness in the chest

Blurred vision

Chest pain or discomfort

Confusion

Dizziness

Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Fainting

Fast or irregular heartbeat

Headache

Lightheadedness, dizziness, or fainting

Loss of consciousness

Nervousness

Pounding in the ears

Slow or fast heartbeat

Sweating

Unusual tiredness or weakness

Bleeding gums

Bruising

Coughing up blood

Difficulty with breathing or swallowing

Headache, sudden and severe

Increased menstrual flow or vaginal bleeding

Nausea or vomiting

Nosebleeds

Paralysis

Prolonged bleeding from cuts

Red or black, tarry stools

Red or dark brown urine

Weakness

Brilinta Controversy

AstraZeneca obtained approval for Brilinta largely on the basis of PLATO, a clinical trial that involved 18,000 patients and compared Brilinta to its main competitor, Plavix. Overall, the study concluded that Brilinta-plus-aspirin was more effective than Plavix-plus-aspirin at preventing heart attack, stroke, and death.

In 2013, FDA reviewers writing in the International Journal of Cardiology raised serious concerns about the reliability of PLATO, due to what they said were irregularities with the study. That October, the U.S. Department of Justice opened an investigation into the clinical trial. However, the investigation ended one year later, with prosecutors taking no action.